Finding Opportunities for Clinical Care and Trial Participation Among Underrepresented Samples

Completed

• Conditions: Pregnancy Related
• Interventions: Behavioral: Focus Group

• Registration Number: NCT03390023
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

Focus groups for Hispanic women who are pregnant and their close family members to assess attitudes, barriers and cultural beliefs involved in participation in clinical trials

Detailed Description

This is a qualitative study conducted with Hispanic pregnant women and their families. Focus groups for Hispanic pregnant women will run concurrent to groups for their close family member, but in separate rooms. Each focus group session of approximately 8-10 participants is expected to last 60-90 minutes and will be led by an experienced moderator who is fluent in Spanish. All discussions will be audio taped and will be kept confidential. Information learned will be used to refine clinical trial procedures and ensure our model of recruitment and retention in the parent ADORE Trial (NCT02626299) is culturally and linguistically acceptable and feasible.

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2017-12-26
• Study First Posted: 2018-01-04
• Study Start: 2018-03-14
• Primary Completion: 2018-05-10
• Study Completion: 2018-05-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-07
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Hispanic women between the ages of 18.0-49.99 yrs old who have been pregnant within the past 5 years OR a close family member
• Speak and understand Spanish

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hispanic Women	Focus Group	Hispanic women who have been pregnant within the past 5 years.
Close Family Member	Focus Group	Close family member of participants in Group 1 - Hispanic Women.

Primary Outcome Measures

Name	Time	Method
Exploratory results from focus groups: access to and attitudes towards prenatal care	1 year	Qualitative description of barriers to access in prenatal care
Exploratory results from focus groups: access to and attitudes towards clinical trials	1 year	Qualitative description of perceptions and beliefs regarding clinical trial research

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States